Esperion Expects Preferred Formulary Placement For Oral Cholesterol Drug Bempedoic Acid

29 Oct 2018

• By Emily Hayes

Final Phase III study for pivotal package of cholesterol drug bempedoic acid shows LDL-lowering efficacy and a clean safety profile, paving the way for filings in the first half of 2019.

Evening scene asphalt international race track with starting or end line, digital imaging recomposition background.

Based on early negotiations with payers, Esperion Therapeutics Inc. is counting on preferred formulary status and reasonable out-of-pocket copays for its oral cholesterol drug bempedoic acid, which just passed its final Phase III study, putting to rest concerns about safety and paving the way for filings in 2019.

Bempedoic acid is a first-in-class once-daily ATP citrate lyase (ACL) inhibitor that reduces cholesterol biosynthesis and lowers LDL-cholesterol (LDL-C) through up-regulation of the LDL receptor

Esperion is developing the drug as a monotherapy and as part of a fixed combination pill with Merck & Co. Inc.'s Zetia (ezetimibe). The Phase III program includes four studies of the drug as a monotherapy and one in combination with Zetia (see box) in patients with atherosclerotic cardiovascular disease (ASCVD) and heterozygous familial hypercholesterolemia (HeFH)

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